UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015854
Receipt number R000018450
Scientific Title Comparison of the efficacy of branched chain amino acid with maltodextrin in outpatient rehabilitation for elderly adults with disabilities: Cross-over trial
Date of disclosure of the study information 2014/12/04
Last modified on 2020/07/13 09:33:05

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Basic information

Public title

Comparison of the efficacy of branched chain amino acid with maltodextrin in outpatient rehabilitation for elderly adults with disabilities: Cross-over trial

Acronym

Comparison of the efficacy of amino acid with dextrin in outpatient rehabilitation for elderly adults

Scientific Title

Comparison of the efficacy of branched chain amino acid with maltodextrin in outpatient rehabilitation for elderly adults with disabilities: Cross-over trial

Scientific Title:Acronym

Comparison of the efficacy of amino acid with dextrin in outpatient rehabilitation for elderly adults

Region

Japan


Condition

Condition

Elderly adults with disabilities

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Using cross-over trial, This study examined the efficacy of one or two session a week of exercise combined with branched chain amino acid supplementation to physical function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Upper and lower limb isometric strength(Leg press, abduction, knee extension, Rowing)

Key secondary outcomes

Physical activity
(Frenchay activities index)
Grip strength
Performance test
(Timed up and go test, Functional reach test)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Branched amino acid supplement
6g/ 3 months
Washout period/ 1 month
Maltodextrin 6g/ 3 months

Interventions/Control_2

Maltodextrin 6g/ 3 months
Washout period/ 1 month
Branched amino acid supplement
6g/ 3 months

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Elderly adults with disabilities, Japanese who utilize Long-term Care Insurance.
2) Eligible to training with utilize of muscle training machine.

Key exclusion criteria

1)Persons with deglutition disorder
2)Persons with dementia
3)Persons with diabetes who need to insulin injections
4)Persons with progressive disorder of the nervous system and muscle
5)Persons with the depression or schizophrenic disorder
6)Persons with untreated cardiovascular disorder
7)Persons with renal disorder who need to dietary restriction
8)Persons who need to limitetion of physical activity

Target sample size

51


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Ikeda

Organization

Tokyo Medical and Dental University Graduate school

Division name

Department of Rehabilitation Medicine

Zip code

113-8510

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

+81-03-3813-6111

Email

tikeda-tmd@umin.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Ikeda

Organization

Tokyo Medical and Dental University Graduate school

Division name

Department of Rehabilitation Medicine

Zip code

113-8510

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

+81-03-3813-6111

Homepage URL


Email

tikeda-tmd@umin.ac.jp


Sponsor or person

Institute

Shonan Kamakura general hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese Physical Therapy Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization

Tokushukai Group Ethical Committee

Address

1-8-7,Koji-machi,Chiyoda-ku,Tokyo 102-0083,Japan

Tel

+81-03-3263-4801

Email

hisamatsu@mirai-iryo.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

介護老人保健施設リハビリケア湘南かまくら(神奈川)/Rehabil-Care Shonan Kamakura (health services facility for the aged)(Kanagawa, Japan)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 04 Day


Related information

URL releasing protocol

none

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1139/apnm-2015-0436

Number of participants that the trial has enrolled

52

Results

Using a crossover design, we investigated the effects of exercise therapy combined with BCAA intake on physical function improvement in frail and pre-frail elderly people requiring longterm care. Significant improvements in gross lower limb muscle strength and dynamic balance ability were achieved by combining BCAA intake and exercise therapy. Therefore, it is feasible to achieve these effects using this combined therapy.

Results date posted

2020 Year 07 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Eligible persons were 80 frail and pre-frail elderly adults requiring
long-term care who received outpatient rehabilitation at a
health services facility for the aged.

Participant flow

A single-blinded, randomized, crossover experimental design,with two 3-month periods of exercise with supplementation and a
1-month washout period of exercise without supplementation,
was used.

Adverse events

none

Outcome measures

Evaluations were conducted before starting the intervention, after each 3-month supplementation period (cycles A and B), and after the washout period. Investigators were not blind to group allocation. Investigators determined upper and lower limb isometric strength, grip strength, Timed Up and Go test (TUG) and Functional Reach Test (FRT) performance, Frenchay Activities Index(FAI), and the number of rehabilitation sessions. The following demographic data were collected from clinical records: age, sex, body mass index (BMI), comorbidity index, duration of outpatient rehabilitation, and underlying diseases (cranial nerve disease, musculoskeletal disease, and peripheral cardiovascular disease).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 08 Month 12 Day

Date of IRB

2013 Year 08 Month 12 Day

Anticipated trial start date

2013 Year 08 Month 20 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2014 Year 05 Month 30 Day

Date trial data considered complete

2014 Year 05 Month 30 Day

Date analysis concluded

2014 Year 10 Month 31 Day


Other

Other related information

none


Management information

Registered date

2014 Year 12 Month 04 Day

Last modified on

2020 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name